[Federal Register Volume 86, Number 234 (Thursday, December 9, 2021)]
[Notices]
[Pages 70147-70148]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26677]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA 937]


Importer of Controlled Substances Application: Fresenius Kabi 
USA, LLC

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Fresenius Kabi USA, LLC has applied to be registered as an 
importer of basic class(es) of controlled substance(s). Refer to 
Supplemental Information listed below for further drug information.

DATES: Registered bulk manufacturers of the affected basic class(es), 
and

[[Page 70148]]

applicants therefore, may file written comments on or objections to the 
issuance of the proposed registration on or before January 10, 2022. 
Such persons may also file a written request for a hearing on the 
application on or before January 10, 2022.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DPW, 
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a 
hearing must be sent to: Drug Enforcement Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 
requests for a hearing should also be sent to: (1) Drug Enforcement 
Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, 
Springfield, Virginia 22152; and (2) Drug Enforcement Administration, 
Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, 
Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this 
is notice that on September 8, 2021, Fresenius Kabi USA, LLC, 3159 
Staley Road, Grand Island, New York 14072-2028, applied to be 
registered as an importer of the following basic class of controlled 
substance:

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                                           Drug
          Controlled substance             code          Schedule
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Remifentanil...........................     9739  II
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    The company plans to import the listed controlled substances for 
bulk manufacture. No other activity for this drug code is authorized 
for this registration.
    Approval of permit applications will occur only when the 
registrant's business activity is consistent with what is authorized 
under 21 U.S.C. 952(a)(2). Authorization will not extend to the import 
of Food and Drug Administration-approved or non-approved finished 
dosage forms for commercial sale.

Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021-26677 Filed 12-8-21; 8:45 am]
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